Project Hope: Hospital Visit is an Opportunity for Prevention and Engagement With HIV-positive Crack Users

NCT00447798 | Completed DMC

• 2 other identifiers: AAAK31561R01DA017612
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed study uses a two-arm randomized experimental design to evaluate the efficacy of a brief, theoretically-guided, "Prevention Care Advocate" intervention with HIV-positive crack users. Study participants will be recruited from the HIV inpatient hospital wards of two inner-city hospitals that serve a similar population of HIV-positive patients: Jackson Memorial Hospital (JMH) in Miami, Florida and Grady Memorial Hospital (GMH) in Atlanta, Georgia.

Conditions

HIV Infections; Crack Cocaine Use; Risky Sexual Behavior

Keywords

HIV positive; crack cocaine user; inpatient hospital setting; HIV knowledge; motivation; perceived self-efficacy; risky sexual behavior; HIV seronegativity

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of a brief, theoretically-based intervention in reducing unprotected sexual intercourse by HIV-positive crack users recruited from the inpatient/hospital setting.

  1 year

Secondary Outcomes (1)

• The impact of the intervention on secondary outcomes including the increased use of HIV primary outpatient care and readiness for and entry to drug treatment, will also be evaluated.

  1 year

Study Arms (2)

Prevention Care Advocate

EXPERIMENTAL

Prevention Care Advocate (PCA) intervention contains elements based on cognitive-behavioral theories and strengths-based case management. Intervention arm participants will undergo an 8 session intervention comprised of three components: 1) An individual strengths-based case management approach aimed at motivating participants to seek or maintain their engagement with HIV primary care and drug treatment; 2) A cognitive-behavioral, skills-building approach to increase participants' risk reduction knowledge, skills, and perceived self-efficacy as well as intention to change high risk transmission behaviors; and 3) A community placement in which study participants will have the opportunity to practice their advocacy skills in prevention and care setting.

Behavioral: Prevention Care Advocate

Standard of Care

NO INTERVENTION

Standard of Care (SOC) condition involves standard practice, consisting of usual inpatient/hospital services provided within normal clinical practice, plus a brief educational session consisting of the review of the topics in the "Living with HIV" brochure published by the Centers for Disease Control and Prevention (CDC).

Interventions

Prevention Care Advocate BEHAVIORAL

Prevention Care Advocate: 8 Session intervention combining cognitive-behavioral skill building \& strengths based case management

Prevention Care Advocate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive
• Sexually active
• Recruited from inpatient/hospital setting
• Crack user

You may not qualify if:

• HIV negative
• Not sexually active
• Not recruited from inpatient/hospital setting
• Non crack user

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Miami Hospital & Clinics/ Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Grady Health System-Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Conditions

HIV Infections; HIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lisa R Metsch, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

• Carlos del Rio, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stephen Smith Professor of Sociomedical Sciences and Chair, Department of Sociomedical Sciences

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 15, 2007
• Study Start: June 1, 2005
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

US (2)